Closys Rinse
FDA Label NDC 58578-0613

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rowpar Pharmaceuticals, Inc. for the product Closys (NDC 58578-0613). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, otc - keep out of reach of children, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrogen Peroxide 1.5% (w/v)

Purpose

Oral debriding agent
Oral wound cleanser

Uses

  • For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
  • Assist in the removal of foreign material from minor oral wounds.

Otc - Keep Out Of Reach Of Children

Do not use this product for more than 7 days unless directed by a dentist, or physician.

When using this product, do not swallow.

Stop use and ask a doctor if

  • sore mouth symptoms do not improve within 7 days.
  • irritation, pain or redness persists or worsens.
  • swelling, rash or fever develops.

    • Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older

  • Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out
  • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician

    • Children 6 years to under 12 years of age: supervise use

    Children under 6 years of age: do not use

Other Information

  • Do not use if safety seal is broken or missing
  • Cap tightly
  • Keep away from direct sunlight
  • Store at room temperature, 68 to 77°F (20 to 25°C)

Inactive Ingredients

water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid

Questions Or Comments?

call 1-800-643-3337

Other

Packaging

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS®
Oral Debriding Agent

MOUTH
SORES

SENSITIVE
MOUTH RINSE

PROMOTES HEALING

HELPS CLEANSE & PROMOTE HEALING OF
ORAL SORES, MOUTH BURNS & IRRITATION

For Canker Sores, Cheek Bites,
Irritation from Dentures or Braces,
Gum Irritation

Non Burning, Alcohol-Free
Formula

Gentle Mint

16 fl oz (473mL)

52516-75

Front Label (Front Label)

Front Label (Front Label)

Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807
1 (800) 643-3337 closys.com

52516-76

Back Label (Back Label)

Back Label (Back Label)

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